08.01.08

ENZI APPLAUDS SENATE PASSAGE OF CRITICAL ANIMAL DRUG LEGISLATION

Washington, D.C. – U.S. Senator Mike Enzi (R-Wyo.), Ranking Member of theSenate Health, Education, Labor and Pensions (HELP) Committee, today applauded theSenate for approving legislation to prevent expiration of the Animal Drug User Fee Act(ADUFA), which provides the Food and Drug Administration (FDA) with the resourcesto evaluate and approve new drugs for animals in a timely and effective manner. The billalso would create a new user fee program for generic animal drugs. “Pet owners, farmers, ranchers, and veterinarians rely on FDA’s ability toevaluate and approve life-saving drugs for animals,” Enzi said. “By reauthorizingADUFA, the Senate will keep this important program running, and will ensure that FDAcan retain the talent and expertise of its valuable employees. “ADUFA has been a success, and we should build on that success by creating asimilar user fee program for generic animal drugs. Only by providing FDA with theresources it needs to approve generic drugs can we tap into their cost-saving benefits.”The Senate approved the “Animal Drug User Fee Amendments of 2008,” H.R.6432, today without objection, after the House of Representatives passed the billWednesday. The bill reauthorizes the Animal Drug User Fee Act (ADUFA) and createsa new Animal Generic Drug User Fee Act. It also includes a bipartisan provision toexpand and streamline the reporting of antibiotics in animals, and two technicalcorrections to the FDA reform bill, PL 110-85, which Congress enacted last year. “I am disappointed that this bill contains just two of several technical changesneeded to implement properly the FDA reforms we enacted last year,” Enzi said. “Thefull package of technical corrections is critical to ensure that key safety andaccountability provisions in the bill work as Congress intended. I look forward tocontinuing to work with my colleagues to complete the full technical correctionspackage.” ####

Press Contact

Craig Orfield (202) 224-6770